UCB Pharma's CIMZIA Receives FDA Approval as First Treatment for Non-Radiographic Axial Spondyloarthritis

VCBeat (WeChat Official Account: vcbeat) has learned that global biopharmaceutical company UCB Pharma announced today that the U.S. Food and Drug Administration (FDA) has approved its injectable drug, CIMZIA, for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) with signs of inflammation. This FDA approval makes CIMZIA the first and only medication worldwide indicated for the treatment of nr-axSpA. CIMZIA is also FDA-approved for the treatment of ankylosing spondylitis (AS), rheumatoid arthritis (RA), psoriatic arthritis, plaque psoriasis, and Crohn’s disease.

UCB Pharma, founded in 1928, is a biopharmaceutical and specialty chemicals company focused on two therapeutic areas: central nervous system disorders and immunology. UCB Pharma provides small-molecule and large-molecule solutions to medical specialists for the treatment of serious diseases. The company also maintains activities in the primary care sector. As of December 31, 2008, UCB Pharma had multiple wholly-owned subsidiaries and R&D facilities in the United States, Canada, Europe, Asia, South America, and Australia. Between 2004 and 2018, it completed financing totaling $100 million, secured investments amounting to $218 million, and acquired four healthcare companies.

Non-radiographic axial spondyloarthritis (nr-axSpA) typically onset in patients under the age of 45. It is a chronic inflammatory disease that is often difficult to diagnose, making it challenging for patients to receive appropriate treatment. The pathological features of nr-axSpA primarily affect the spine and sacroiliac joints. In the detection of nr-axSpA, there are no definitive X-ray findings that can diagnose sacroiliitis; only more sensitive magnetic resonance imaging (MRI) may reveal evidence of active sacroiliac joint inflammation. Historically, due to a lack of understanding of the disease’s history, progression, and subsequent treatment options, nr-axSpA has not been widely or adequately recognized, leading to delayed diagnosis in many patients. Patients with nr-axSpA often suffer from severe inflammatory back pain, stiffness, fatigue, and sleep disturbances, accompanied by declined physical function, reduced quality of life, impaired productivity at work and at home, and decreased social participation.

The safety profile of CIMZIA in patients with non-radiographic axial spondyloarthritis (nr-axSpA) is consistent with that observed in patients with rheumatoid arthritis (RA) and in previous CIMZIA patient populations receiving similar treatment. According to the latest labeling, the initial dosing regimen of CIMZIA for adult patients with nr-axSpA is 400 mg (administered as two subcutaneous injections of 200 mg each), followed by maintenance doses of 200 mg or 400 mg administered every two weeks.

CIMZIA therapy met the ASAS-40 response criteria for axial spondyloarthritis, indicating that 47.8% of patients treated with CIMZIA achieved an improvement of more than 40% in their ankylosing spondylitis assessment scores, compared to only 11.4% of patients receiving placebo at Week 12.

Cassie Shafer, CEO of the Spondylitis Association of America, stated, “This represents a significant advancement in the field of spondyloarthritis research. Expanded treatment options, earlier diagnosis, and heightened awareness will lead to better outcomes for patients.”

Emmanuel Caeymaex, Executive Vice President and Head of Immunology at UCB Pharma, stated: “The FDA’s approval of CIMZIA for the treatment of adult axial spondyloarthritis will have a significant impact on many patients living with this condition. We are proud that UCB Pharma is at the forefront of developing valuable therapeutic solutions, providing treatment options for patients with a substantial disease burden. UCB Pharma remains committed to improving care and treatment outcomes for patients with axial spondyloarthritis.”

“Non-radiographic axial spondyloarthritis requires early diagnosis, followed by prompt initiation of appropriate treatment. However, for some patients, it may take nearly ten years from the onset of symptoms to receive a definitive diagnosis. The FDA’s recent approval of CIMZIA injection signifies that patients with spondyloarthritis will now be able to more easily and effectively alleviate inflammatory pain, stiffness, and other related symptoms, ultimately improving their quality of life,” said Atul Deodhar, M.D., of Oregon Health & Science University in Maryland.

(Compiled by Wang Shuijing)